Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 1 of 37

COPYRIGHT 2009 BY EAST COAST VALIDATION SERVICES, LLC.

VALIDATION PROTOCOL

Prepared By:

East Coast Validation Services, LLC. Date

Reviewed By:

Acme Biotech Manufacturing Date

Reviewed By:

Acme Biotech Facilities Date

Approved By:

Acme Biotech Quality Assurance Date

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 2 of 37

TABLE OF CONTENTS

1.0  OBJECTIVE ............................................................................................................................... 3 

2.0  SCOPE ...................................................................................................................................... 3 

3.0  ASSOCIATED DOCUMENTATION .............................................................................................. 3 

4.0  SYSTEM DESCRIPTION ............................................................................................................ 3 

5.0  DOCUMENTATION .................................................................................................................... 4 

6.0  RESPONSIBILITIES ................................................................................................................. 4 

7.0  INSTALLATION VERIFICATION ............................................................................................... 5 

8.0  OPERATION VERIFICATION .................................................................................................. 10 

9.0  EXCEPTION RESOLUTION AND EXCEUTION SUMMARY ........................................................ 12 

ATTACHMENT 1: SIGNATURE LOG .................................................................................................... 14 

ATTACHMENT 2: CRITICAL COMPONENT INFORMATION VERIFICATION ....................................... 15 

ATTACHMENT 3: SUPPORT DOCUMENTATION VERIFICATION ........................................................ 16 

ATTACHMENT 4: MATERIALS OF CONSTRUCTION VERIFICATION .................................................. 17 

ATTACHMENT 5: PIPING MODIFICATIONS DOCUMENTATION VERIFICATION ............................... 18 

ATTACHMENT 6: UTILITY CONNECTION VERIFICATION ................................................................. 19 

ATTACHMENT 7: TEST INSTRUMENT CALIBRATION VERIFICATION ............................................... 20 

ATTACHMENT 8: GENERAL INSTALLATION REVIEW ........................................................................ 21 

ATTACHMENT 9: STANDARD OPERATING PROCEDURE REVIEW ..................................................... 22 

ATTACHMENT 10: PUMP FUNCTIONAL VERIFICATION .................................................................... 23 

ATTACHMENT 11: DISCREPANCY RESOLUTION ............................................................................... 25 

ATTACHMENT 12: DEVIATION RESOLUTION .................................................................................... 26 

ATTACHMENT 13: EXECUTION SUMMARY ........................................................................................ 27 

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 3 of 37

1.0 OBJECTIVE

The objective of this protocol is to define the Installation and Operation Qualification (IOQ) requirements, as well as the associated Acceptance Criteria for the Alfa Laval Model LKH25 Sanitary Pump P-101, located in the Mechanical Services Area of the Acme Biotech facility located in Thule, Greenland. This IOQ will provide documented evidence that Pump P-101 has been installed and operates per the manufacturer’s specifications and in accordance with Acme Biotech requirements.

2.0 SCOPE

This IOQ protocol will address the replacement of an existing TriClover model 218 pump with an Alfa Laval model LKH25 pump. (Refer to Change Control Summary VC-xxxx.)

Pump P-101 is a component of Clean In Place (CIP) system CIP-012. As this IOQ will document that the Alfa Laval model LKH25 pump is equivalent to the TriClover model 218 pump in terms of critical attributes required for effective cleaning, the functionality of CIP-012 is beyond the scope of this protocol.

3.0 ASSOCIATED DOCUMENTATION

Document Number Document Title

VC-xxxx Change Control Summary, Replacement of a TriClover/Alfa Laval Model 218 Pump with an Alfa Laval Model LKH25

4.0 SYSTEM DESCRIPTION

Pump P-101 was previously a TriClover model 218 centrifugal pump used to deliver cleaning solutions and rinsewater for CIP-012. It has been replaced with an Alfa Laval model LKH25 centrifugal pump. Specifications for both pumps are summarized in the following table:

Specification Current State Proposed State

Manufacturer/Model TriClover 218 Alfa Laval LKH25

Impeller diameter 7” 7.48”

Motor HP/speed 5 HP / 1800 RPM 3 HP / 1800 RPM

Flowrate 80 GPM 80 GPM

Pressure head 50 FT 50 FT

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 4 of 37

5.0 DOCUMENTATION

The Final Validation Package for this unit will include the results, observations, and conclusions from the execution of this protocol. All Discrepancies and Deviations observed during the execution of this protocol will be documented and their resolutions approved by Acme Biotech Quality Assurance. A copy of the executed protocol with all completed attachments, all associated exhibits and all approved Discrepancies and Deviations will be included in the Final Validation Package.

When signed by authorized representatives from Acme Biotech Manufacturing, Facilities and Quality Assurance departments, Attachment 9: Execution Summary will indicate that the Installation and Operation Qualification of Pump P-101 is complete and provides documented evidence that it has been installed and operates per the manufacturer’s specifications and in accordance with Acme Biotech requirements.

6.0 RESPONSIBILITIES

6.1. East Coast Validation Services, LLC.

6.1.1. Developing, writing, and reviewing this protocol.

6.1.2. Executing the tests and verifications set forth in this protocol.

6.1.3. Providing a Summary Report that documents and summarizes the execution of this qualification protocol per Section 5.0.

6.1.4. Preparing the Validation Package for review and approval.

6.2. Acme Biotech – Manufacturing and Facilities Departments

6.2.1. Managing the validation project, assisting with scheduling, coordination of materials and information, and providing access to the equipment.

6.2.2. Reviewing, verifying and approving this protocol and the Summary Report. This shall include resolution, if necessary, of any Discrepancies and/or Deviations observed during the execution of the IOQ protocol.

6.2.3. Ensuring that all measuring, recording, and controlling instruments that impact the system operation and/or are required to provide measurements for this qualification are in current calibration to NIST traceable standards before being used to support this qualification.

6.2.4. Maintaining applicable Standard Operating Procedures (SOP’s), including but not limited to system Operation and Preventive Maintenance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 5 of 37

6.3. Acme Biotech – Quality Assurance

6.3.1. Reviewing and approving this protocol for compliance with regulatory expectations and Acme Biotech policies prior to execution.

6.3.2. Reviewing the executed protocol for compliance with the Acceptance Criteria and, if necessary, approving any Discrepancies and/or Deviations occurring during the execution of the protocol.

6.3.3. Reviewing and approving the Summary Report.

7.0 INSTALLATION VERIFICATION

Complete Sections 7.1 thru 7.8 of this IOQ and document all required information on the indicated Attachments for each section. In cases where Expected Results are stated in Attachment entries, the term “As Expected” can be entered if the Observed Results are consistent with the Expected Results. If any results do not meet Acceptance Criteria, document these results as described in Section 9.1: Discrepancy Resolution. If any deviations from the protocol procedures are made, indicate them as described in Section 9.2: Deviation Resolution.

7.1. Signature Log

7.1.1. Objective

The objective of the Signature Log is to provide traceability of signatures and initials of those completing attachments or reviewing and signing required documents within the IOQ protocol. Signature also indicates that each participant has read and understood the protocol prior to review or execution.

7.1.2. Procedure

All personnel recording data on attachments, reviewing and signing attachments or reviewing and signing required documents within the protocol must record the required information on Attachment 1: Signature Log.

7.1.3. Acceptance Criteria

Signatures and initials of all personnel recording data for this protocol or reviewing the executed protocol are recorded on Attachment 1.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 6 of 37

7.2. Critical Component Information Verification

7.2.1. Objective

The objective of this verification is to document that the pump critical components As Installed are consistent with specifications.

7.2.2. Procedure

Record nameplate information for the pump, motor and rotor and confirm that this information is consistent with specifications using Attachment 2: Critical Component Information Verification.

7.2.3. Acceptance Criteria

The pump, motor and rotor nameplate information is consistent with the documented specifications.

7.3. Support Documentation Verification

7.3.1. Objective

The objective of this verification is to confirm that documentation required to support the installation, operation and maintenance of the model LKH25 pump is available.

7.3.2. Procedure

Verify that the following information is available:

7.3.2.1. Pump cut sheet/specifications

7.3.2.2. Pump installation instructions

7.3.2.3. Pump Operation and Maintenance (O&M) manual

7.3.2.4. Manufacturer’s Pump Curve data

Also verify that the CIP-012 Piping and Instrumentation Diagram (P&ID) has been revised to document that P-101 is now an Alfa Laval Model LKH25.

Document these verifications using Attachment 3: Support Documentation Verification, and attach copies of the above documents as Exhibits to the executed protocol.

7.3.3. Acceptance Criteria

The above documentation is confirmed to be on hand to support the installation, operation and maintenance of pump P-101.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 7 of 37

7.4. Materials of Construction Verification

7.4.1. Objective

The objective of this section is to document that the Product Contact MOC of the Alfa Laval model LKH25 pump are consistent with the corresponding TriClover model 218 Product Contact MOC.

7.4.2. Procedure

Review the manufacturer’s documentation for the Alfa Laval model LKH25 pump and confirm that the Product Contact MOC are consistent with the corresponding TriClover model 218 Product Contact MOC. Document this confirmation using Attachment 4: Materials of Construction Verification, and attach copies of the above documents as Exhibits to the executed protocol.

7.4.3. Acceptance Criteria

The Product Contact MOC of the Alfa Laval model LKH25 pump are documented to be consistent with the corresponding TriClover model 218 Product Contact MOC.

7.5. Piping Modifications Documentation Verification

7.5.1. Objective

The objective of this section is to confirm that any piping modifications implemented during the installation of the Alfa Laval model LKH25 pump are properly documented.

7.5.2. Procedure

Obtain copies of the following documentation associated with the piping modifications required to install the Alfa Laval model LKH25 pump with the CIP-012 system:

7.5.2.1. Isometric drawings

7.5.2.2. Weld logs and weld inspection reports

7.5.2.3. Pressure/leak test reports

7.5.2.4. Passivation reports

Attach copies of these documents as Exhibits to the executed protocol. Document this using Attachment 5: Piping Modifications Documentation Verification.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 8 of 37

7.5.3. Acceptance Criteria

The above documents available, are included as Exhibits to the executed protocol, and confirm that the Alfa Laval model LKH25 pump is properly installed within the CIP-012 system.

7.6. Utility Connection Verification

7.6.1. Objective

The objective of this section is to document that the electrical service provided to P-101 meets specifications.

7.6.2. Procedure

7.6.2.1. Using a calibrated voltmeter, verify that 208 VAC 3Φ power is supplied to P-101. Document this verification using Attachment 6: Utility Connection Verification.

7.6.2.2. Also document the circuit breaker that serves P-101 on Attachment 6 and confirm that it is properly sized.

7.6.3. Acceptance Criteria

7.6.3.1. The voltage provided to P-101 is 208 VAC 3Φ ± 20 VAC.

7.6.3.2. The circuit breaker serving P-101 is documented on Attachment 6.

7.6.3.3. The circuit breaker serving P-101 has a capacity of at least 20A.

7.7. Test Instrument Calibration Verification

7.7.1. Objective

The objective of this section is to document that any Test Instruments used during the execution of this protocol have been properly calibrated.

7.7.2. Procedure

For each Test Instrument used during protocol execution, record the instrument type, serial number, Calibration Date and Calibration Due Date on Attachment 7: Test Instrument Calibration Verification. Attach copies of each instrument’s Calibration documentation as Exhibits to the executed protocol.

7.7.3. Acceptance Criteria

All Test Instruments used during the execution of this protocol are documented to be in a calibrated state during execution.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 9 of 37

7.8. General Installation Review

7.8.1. Objective

The objective of this section is to document that P-101 has been installed properly according to general GMP expectations and Acme Biotech requirements.

7.8.2. Procedure

7.8.2.1. Visually verify that P-101 is securely connected to CIP-012 piping with no visible leaks.

7.8.2.2. Verify that P-101 has been has been firmly secured to the floor with adequate accessibility for service.

7.8.2.3. Visually verify that P-101 is correctly tagged.

Document these verifications using Attachment 8: General Installation Review.

7.8.3. Acceptance Criteria

7.8.3.1. P-101 is securely connected to CIP-012 piping with no visible leaks.

7.8.3.2. P-101 is firmly secured to the floor with adequate accessibility for service.

7.8.3.3. P-101 is correctly tagged.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 10 of 37

8.0 OPERATION VERIFICATION

8.1. Standard Operating Procedure Review

8.1.1. Objective

The objective of this section is to document that Acme Biotech Standard Operating Procedures (SOPs) have been revised to reflect the pump change from TriClover model 218 to Alfa Laval model LKH25.

8.1.2. Procedure

Review Acme Biotech SOPs for the following subjects and verify that any references to a TriClover model 218 pump have been revised to refer to an Alfa Laval model LKH25 pump:

8.1.2.1. Operation

8.1.2.2. Maintenance (including logbooks)

8.1.2.3. Spare parts inventory

Document this review using Attachment 9: Standard Operating Procedure Review.

8.1.3. Acceptance Criteria

The above identified SOPs have been revised as required to account for the pump change from TriClover model 218 to Alfa Laval model LKH25.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 11 of 37

8.2. Pump Functional Verification

8.2.1. Objective

The objective of this section is to document that P-101, as installed per Section 7 of this protocol, functions per Acme Biotech requirements.

8.2.2. Procedure

8.2.2.1. Briefly actuate P-101 and verify that the rotor rotates in the correct direction.

8.2.2.2. Operate CIP-012 per Acme Biotech SOP under normal operating conditions, and verify that P-101 can maintain a flowrate of at least 80 gallons per minute (GPM).

8.2.2.3. Operate CIP-012 per Acme Biotech SOP, and adjust a manual valve or pressure control valve to obtain a backpressure to the pump of 50 feet Water Column (21.5 psi). Verify that P-101 maintains a flowrate of at least 80 GPM.

Note: Flowrate can be verified either by using a calibrated flow element inline with P-101 or by delivering the water flow to a container and measuring the time required to fill to a known volume using a calibrated timer.

8.2.2.4. Document these verifications using Attachment 10: Pump Functional Verification.

8.2.3. Acceptance Criteria

8.2.3.1. The P-101 rotor is confirmed to rotate in the correct direction.

8.2.3.2. P-101 can deliver 80 GPM under normal operating conditions.

8.2.3.3. P-101 can deliver 80 GPM with a backpressure of 50 feet Water Column (21.5 psi).

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 12 of 37

9.0 EXCEPTION RESOLUTION AND EXCEUTION SUMMARY

9.1. Discrepancy Resolution

9.1.1. Objective

The purpose of the Discrepancy Resolution form is to document any data that did not meet the Acceptance Criteria, provide actions required to resolve the discrepancy, and/or to provide a justification for why the discrepancy is acceptable.

9.1.2. Procedure

Document all discrepancies noted during the execution of the IOQ protocol on Attachment 11: Discrepancy Resolution, along with resolutions or justifications. Circulate the completed Attachment 11 for appropriate approval.

9.1.3. Acceptance Criteria

All discrepancies must be fully documented and resolved prior to approval of the Summary Report in one of three ways:

9.1.3.1. Justify why the change from the Acceptance Criteria is acceptable.

9.1.3.2. Physically change the item in question to conform to specification.

9.1.3.3. Replace a failing component and run the study again.

9.2. Deviation Resolution

9.2.1. Objective

The purpose of the Deviation Resolution form is to document any deviations from the approved protocol, and to provide a justification or resolution for why the deviation is acceptable.

9.2.2. Procedure

Document all deviations noted during the execution of the IOQ protocol on Attachment 12: Deviation Resolution, along with justifications or resolutions. Circulate the completed Attachment 12 for appropriate approval.

9.2.3. Acceptance Criteria

All deviations must be fully documented, justified and approved prior to approval of the Summary Report.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 13 of 37

9.3. Execution Summary

9.3.1. Objective

The purpose of the Execution Summary section of this protocol is to document that all Attachments have been executed, that all associated Attachment Exhibits are identified and attached to the executed protocol, and that all Discrepancies and Deviations observed during the execution of this protocol have been properly documented and acceptably resolved. The Execution Summary will document that all Acceptance Criteria have been met, or that a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

9.3.2. Procedure

Review each protocol Attachment and confirm that it has been properly executed and documented and that all Attachment Exhibits are included with the executed protocol. Review test data and confirm that all Acceptance Criteria have been met, or that a Discrepancy or Deviation Report, documenting why the specific test results not meeting Acceptance Criteria are acceptable, has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance. Document this review using Attachment 13: Execution Summary.

Circulate the completed Attachment 13 for approval by Acme Biotech Manufacturing, Facilities and Quality Assurance.

9.3.3. Acceptance Criteria

9.3.3.1. All protocol tests are confirmed to have been properly executed and documented on appropriate Attachments.

9.3.3.2. All Exhibits associated with each Attachment are identified and attached to the executed protocol.

9.3.3.3. All Acceptance Criteria have been met, or all Discrepancies and Deviations observed during the execution of this protocol have been properly documented and acceptably resolved.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 14 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 1: SIGNATURE LOG

The signatures below indicate that each signatory has read and understood this protocol prior to executing or reviewing it.

Printed Name Signature Initials Company / Department Date

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 15 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 2: CRITICAL COMPONENT INFORMATION VERIFICATION

Verify that the following information is consistent with Acme Biotech and the manufacturer’s specifications:

Item Specified As Found

As Found consistent

with Specification?

Yes/No

Verified By

Initials Date

Pump Alfa Laval Model LKH25

Motor 3 HP / 1800 RPM

Rotor 7.48”

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 16 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 3: SUPPORT DOCUMENTATION VERIFICATION

Verify that the following documentation is available to support the installation, operation and maintenance of pump P-101:

Document Title / Number Exhibit Number

Verified By

Initials Date

Cut Sheet/ Specifications

Installation Instructions

Operation and Maintenance Manual

Manufacturer’s Pump Curve Data

Document Number/Revision Revision

Required? Yes/No

Exhibit Number

Verified By

Initials Date

Acme Biotech P&ID:

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 17 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 4: MATERIALS OF CONSTRUCTION VERIFICATION

Verify that the Product Contact MOC of the Alfa Laval model LKH25 pump are consistent with the corresponding TriClover model 218 MOC:

Product Contact Surface(s)

TriClover model 218 MOC

Alfa Laval model LKH25 MOC

Consistent? Yes/No Exhibit

Verified By

Initials Date

Pump housing

Pump rotor

Pump seals (elastomers)

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 18 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 5: PIPING MODIFICATIONS DOCUMENTATION VERIFICATION

Obtain copies of the following documentation associated with any piping modifications that were implemented during the installation of P-101. If any of this documentation is Not Applicable, enter N/A in the appropriate spaces.

Document Title/Number Exhibit Verified By

Initials Date

Isometric drawing(s)

Weld log(s)

Weld Inspection Report(s)

Pressure/Leak Test Reports

Passivation Report(s)

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 19 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 6: UTILITY CONNECTION VERIFICATION

Verify that P-101 is properly connected to electrical power per the below table:

Item Specified As Found

As Found Consistent

with Specification?

Yes/No

Verified By

Initials Date

Voltage 208 VAC 3Φ ± 20 VAC

Breaker ID Not Specified

Breaker Capacity ≥ 20 A

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 20 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 7: TEST INSTRUMENT CALIBRATION VERIFICATION

Document the calibration status of all Test Instruments used during the execution of this protocol in the table below:

Instrument Description Instrument Use Instrument Serial

Number

Calibration Date/ Calibration Due

Date Exhibit

Verified By

Initials Date

Digital multimeter Voltage verification

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 21 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 8: GENERAL INSTALLATION REVIEW

Specification As Found Acceptable? Yes/No

Verified By

Initials Date

P-101 is securely connected to CIP-012 with no visible leaks

P-101 is firmly secured to the floor with adequate service access

P-101 is correctly tagged

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 22 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 9: STANDARD OPERATING PROCEDURE REVIEW

Review Acme Biotech SOPs for the following subject s and confirm that they have been revised to reflect that P-101 is now an Alfa Laval model LKH25 pump. If no revisions were required, enter “NR” in the space.

Category SOP Title / Rev Revised? Yes/NR

Verified By

Initials Date

Operation

Maintenance

Equipment logbook(s)

Spare parts inventory

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 23 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

ATTACHMENT 10: PUMP FUNCTIONAL VERIFICATION

Instructions Expected Result Observed Result

Observed Result As Expected?

Yes/No

Verified By

Initials Date

Briefly actuate P-101. Verify that the rotor rotates in the correct direction

Rotor rotates to pump water out of the outlet

Operate CIP-012 per SOP. under normal operating conditions

P-101 maintains a flow of at least 80 GPM under normal conditions.

Flowrate:

Method used to measure flowrate: N/A

Backpressure under normal conditions: N/A

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 24 of 37

Comments:

Reviewed By: _________________________________________________________

Date: _________________________

Instructions Expected Result Observed Result

Observed Result As Expected?

Yes/No

Verified By

Initials Date

Operate CIP-012 per SOP. Adjust a manual valve or pressure control valve to obtain a backpressure of at least 50 feet Water Column (21.5 psi).

P-101 maintains a flowrate of at least 80 GPM.

Flowrate:

Method used to measure flowrate: N/A

Valve used to adjust backpressure: N/A

Observed backpressure:

N/A

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 25 of 37

Reviewed By: ___________________________________

Date: ____________________

Approved By: (QA) ___________________________________

Date: ____________________

ATTACHMENT 11: DISCREPANCY RESOLUTION

Use this attachment to document discrepancies encountered during protocol execution.

(This sheet may be duplicated as necessary)

Discrepancy # Protocol Section(s):

Discrepancy Description:

Investigation:

Resolution / Justification:

Satisfactorily Completed?

(Y/N)

Performed By / Date

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 26 of 37

Reviewed By: ___________________________________

Date: ____________________

Approved By: (QA) ___________________________________

Date: ____________________

ATTACHMENT 12: DEVIATION RESOLUTION

Use this attachment to document deviations from the approved protocol during execution.

(This sheet may be duplicated as necessary)

Deviation # Protocol Section (s):

Deviation Description:

Justification / Resolution for Deviation:

Satisfactorily Completed?

(Y/N)

Performed By / Date

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 27 of 37

ATTACHMENT 13: EXECUTION SUMMARY

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

1 Signature Log Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 28 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

2 Critical Component Information Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 29 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

3 Support Documentation Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 30 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

4 Materials of Construction Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 31 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

5 Piping Modifications Documentation Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 32 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

6 Utility Connection Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 33 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

7 Test Instrument Calibration Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 34 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

8 General Installation Review

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 35 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

9 Standard Operating Procedure Review

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 36 of 37

PROTOCOL ATTACHMENT VERIFICATION VERIFIED BY

# TITLE INITIALS DATE

10 Pump Functional Verification

Execution is complete

Associated Exhibits (list below):

Associated Discrepancies or Deviations (list below)

All associated Discrepancy/Deviation Reports are approved

All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Document Number:

VP-IOQ-09-XXXX ACME BIOTECH

Effective Date:

Version: 000 Installation and Operation Qualification (IOQ) Protocol for the Alfa Laval Model LKH25 Pump

Pump P-101

Page: 37 of 37

EXECUTION SUMMARY APPROVAL

The signatures below signify that the executed Installation and Operation Qualification protocol for the Alfa Laval Model LKH25 Sanitary Pump, Pump P-101, has been reviewed. All protocol tests are confirmed to have been properly executed and documented on appropriate Attachments, all Exhibits associated with each Attachment are identified and attached to the executed protocol, and all Acceptance Criteria have been met, or a Discrepancy or Deviation Report, documenting why the specific test results not meeting Acceptance Criteria are acceptable, has been approved by Acme Biotech. All Acceptance Criteria have been met, or a Discrepancy or Deviation Report documenting why the specific test results not meeting Acceptance Criteria are acceptable has been approved by Acme Biotech Manufacturing, Facilities and Quality Assurance.

Reviewed By:

Acme Biotech Manufacturing Date

Reviewed By:

Acme Biotech Facilities Date

Approved By:

Acme Biotech Quality Assurance Date